Using probiotics to treat gout and high uric acid levels

Probiotics for Gout / Hyperuricemia: A Randomized, Double-blind, Intervention, Parallel Controlled, Multicenter Clinical Trial

This study is testing if adding a probiotic to regular gout treatments can help people with high uric acid levels feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: The Affiliated Hospital of Inner Mongolia Medical University (Academic / other)
• Drugs / interventions: prednisone
• Locations: 1 site (Hohhot, Inner Mongolia)
• Trial ID: NCT04199325 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of the probiotic Lactobacillus Zhang in combination with standard treatments for gout and hyperuricemia. Participants will be randomly assigned to receive either the probiotic or a placebo while continuing their usual uric-acid-lowering medications. The study is designed to be double-blind, ensuring that neither the participants nor the researchers know who is receiving the active treatment. The goal is to determine if the addition of probiotics can improve outcomes for patients suffering from these conditions.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-70 with a history of gout and elevated serum uric acid levels.

Not a fit: Patients with recent gout attacks, secondary hyperuricemia, or significant comorbid conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new, effective treatment option for patients with gout and hyperuricemia.

How similar studies have performed: While the use of probiotics in treating gout is a relatively novel approach, similar studies have shown promise in other inflammatory conditions.

Eligibility criteria

Inclusion Criteria:

Subjects are eligible for inclusion in this study only if they meet all of the following criteria

1. 18-70 years old, gender unlimited ；
2. Previous history of gout ；
3. According to the criteria of gout classification and diagnosis of EULAR / ACR in 2015；
4. fasting serum uric acid ≥ 480 μ mol / L (8mg / dl)

Exclusion Criteria:

If the subjects meet any of the following criteria, they will not be selected ：

1. Gout in the past two weeks ；
2. Secondary hyperuricemia ；
3. Patients with abnormal liver and kidney function (ALT, AST are 1.5 times higher than the normal value, Cr is 1.5 times higher than the upper limit of the normal value；
4. WBC \< 4.0 × 109 / L, PLT \< 100 × 109 / L, HGB \< 90g / L, or other hematological diseases ；
5. bad blood pressure control (BP\>160mmHg/100 mmHg)
6. Type I diabetes or poorly controlled type II diabetes: fasting blood glucose ≥ 8.5mmol/l ；
7. Patients with active peptic ulcer ；
8. Patients with gastrointestinal cancer ；
9. Patients with previous intestinal diseases such as lactose intolerance, irritable bowel syndrome, inflammatory bowel disease and habitual diarrhea ；
10. Use of drugs that affect the metabolism or excretion of uric acid and cannot / cannot be stopped, including azathioprine, 6-mercaptopterin, thiazide diuretics, aspirin (more than 325mg / day) or other salicylates ；
11. Those who need continuous prednisone treatment ；
12. Those who need antibiotic treatment for infectious diseases ；
13. Those with body mass index (BMI) greater than 30 ；
14. people with alcoholism ；
15. People with a history of allergy to Lactobacillus and its products or with high sensitive constitution ；
16. Researchers who have received other drugs within 3 months before screening ；
17. The people who are researchers thinks it is not suitable to participate in the study.

Where this trial is running

Hohhot, Inner Mongolia

• Inner Mongolia Medical College Affiliated Hospital — Hohhot, Inner Mongolia, China (Recruiting)

Conditions Gout; Hyperuricemia; gout; hyperuricemia; probiotics